Introduction
Who is medical treatment intended for – the patient or the healthcare system? In the process of develop-ing a new drug, the need and value of the medication from the patient’s perspective is only asked for via biomedical parameters used in clinical trial situations.
Any new medication that is to be marketed in Europe must undergo a process of approval through the European Agency for the Evaluation of Medicinal Products (EMEA),1 following which it is approved to be sold within the European Community. After regis-tration at a national level (in Sweden) by the Medical Products Agency (MPA),2 which also pro-vides recommendations for treat-ment at a group level, pricing is negotiated and decided by the Pharmaceutical Benefits Board.3
This organisation also decides whether or not the product will be included in the reimbursement system.3 The National Board of Health and Welfare4 provides national guidelines on the treat-ment of certain diseases, and at a regional level, local pharmaceutical committees implement recommen-dations for treatment where specific
brands are recommended for use, based
on documentation and price. Pricing is without exception
decided from the pharmaceutical industry and authorities’ perspec-tive about what is best for the patient. This is mainly a paternalis-tic approach that aims to keep control over drug expenses for the reimbursement authority. In Sweden, patient organisations are not involved in decision-making regarding drug recommendations and pricing.
A typical example of how the process works in practice was
Treatment satisfaction with insulin
glargine in patients with diabetes mellitus
in a university hospital clinic in Sweden
M Annersten Gershater,* A Frid, J Apelqvist
Abstract
Background: Few studies evaluate patients’ perspectives when a new drug is
intro-duced to treat chronic diseases such as diabetes mellitus. The clinical role of a new insulin treatment, in terms of the relationship between higher cost and better treat-ment outcomes (as defined from the patient perspective) has been discussed. We sought to explore patient satisfaction with a new insulin treatment (insulin glargine). At its launch in 2002/3 it was purported to provide constant, peakless insulin release following once- or twice-daily administration, thus leading to fewer hypoglycaemic episodes while providing metabolic control equivalent to that achieved with NPH human basal insulin.
Aims: To investigate the indications used for prescription of a new drug and its
clinical effects on glycosylated haemoglobin (HbA1c) levels, perceived hypoglycaemic events and patient satisfaction.
Methods: The Diabetes Treatment Satisfaction Questionnaire (Status Version,
DTSQ-s), which measures satisfaction with treatment regimen, and perceived frequency of hyperglycaemia and hypoglycemia, was circulated to all living patients who had ever started treatment with insulin glargine at the Department of
Endocrinology at Malmö University Hospital. Medical records of 913 patients were assessed for HbA1clevels at 0 and 12 months after starting insulin glargine therapy.
Results: Completed questionnaires were returned by 615 of 960 patients (64%) who
had ever started insulin glargine. The main indications for starting treatment were physicians’ or nurses’ initiatives, desire for fewer fluctuations and improved metabolic control. HbA1clevels fell by 0.41% for patients with type 1 diabetes and by 0.68% for those with type 2 diabetes. The mean DTSQ-s score was 28.45 for satisfaction, whereas the mean perceived hypoglycaemic/hyperglycaemic events score was 3.
Conclusion: Treatment satisfaction was very high and perceived frequency of
hypoglycaemia/hyperglycaemia was very low. The indications for treatment of insulin glargine are being followed in accordance with national recommendations.
Eur Diabetes Nursing 2009; 6(1): 17–22
Key words
Diabetes treatment satisfaction; insulin glargine; patient perspective; hypoglycaemia; hyperglycaemia Authors M Annersten Gershater, RN, MNSc, Research Nurse A Frid, MD, Phd, Registrar J Apelqvist, MD, Phd, Registrar, Associate Professor
Department of Endocrinology, Malmö University Hospital, Malmö, Sweden
*Correspondence to:
M Annersten Gershater, Department of Endocrinology, Malmö University Hospital Ing 51, SE 205 02 Malmö, Sweden e-mail: magdalena.gershater@skane.se
Received: 21 July 2008
Accepted in revised form: 13 January
observed when the long-acting insulin analogue insulin glargine was launched in Sweden. In May 2005, the MPA recommended that Neutral Protamine Hagedorn (NPH) insulin should be the stan-dard basal treatment for most insulin-treated patients, stating that there is no reason to switch from a well-functioning NPH treatment to insulin glargine or detemir, if the patient has no problems with hypo-glycaemia.5 The MPA also advised that long-acting insulin analogues such as glargine or detemir should be reserved for the following candi-dates:
• Individuals with type 1 diabetes with either frequent nocturnal hypoglycaemia; or
• Individuals in whom the treat-ment goal for HbA1c is not achieved because of recurring hypoglycaemia related to NPH insulin use; or
• Individuals with particular symp-tomatic fluctuations in plasma glucose levels.5
For type 2 diabetes patients, the MPA recommended that insulin glargine or detemir should be reserved for those with recurrent nocturnal hypoglycaemia or people who were not achieving treatment goals for HbA1c because of recur-rent hypoglycaemia related to NPH treatment.5
The MPA recommendations did not take into consideration patient influence in terms of choice or informed choice as described in the National Guidelines on the care and treat-ment of diabetes mellitus4 (which state that patients should be provided with tools to control their disease and how it affects their life), and in the Swedish Diabetes Association’s Funda-mental Principles6 (where the policy of interest describes the patient as a healthcare consumer
who should have the opportunity to receive diabetes care that offers what the individual requires, in order to achieve the agreed treatment goals). Long-acting ins-ulin analogues could be such a tool. Insulin glargine was launched in 2002/2003, claiming to offer better outcomes with regard to stable slow release of insulin following a once-daily injection, thus providing stable and predictive long-acting basal treatment and decreased frequency of hypoglycaemia compared with traditionally used NPH insulin.7The price, conversely, was about twice as much as that for traditionally used NPH insulin. A systematic literature review, which assessed what advan-tages insulin glargine offered com-pared with NPH insulin, revealed that glargine and NPH insulin both reduced hyperglycaemia, that there was no difference in HbA1c levels between the two treatments, and that hypoglycaemia assessment was not standardised in the included studies.8 Consequently, no conclu-sions could be made regarding any reduction of hypoglycaemia.8 Patient satisfaction or quality of life was not an issue. These findings prompted a discussion regarding the clinical role of insulin glargine, which centred on the following issues:
• If this treatment is more expensive and does not provide better out-comes compared with NPH, could it be defended?
• How is ‘outcome of treatment’ defined?
• What is the patient perspective regarding the new therapeutic option?
Aims
The present study sought to investi-gate the indications for prescribing a new drug (insulin glargine) and its clinical outcomes on HbA1c lev-els, perceived hypoglycaemic events and patient satisfaction.
Patients and methods
The Department of Endocrinology at Malmö University Hospital pro-vides care for most of the diabetes type 1 patients living in the town (which had 269 142 inhabitants as of 1 January 2005) and type 2 dia-betes patients referred by general practitioners. The department is also responsible for patients from the wider region who have diabetes-related complications. The clinic was visited by 2289 diabetes patients >18 years old (with type 1 or type 2 diabetes) during 2004, of whom 360 underwent a 1–5-day problem-based learning educational pro-gramme.9
The Diabetes Treatment Sat-isfaction Questionnaire (DTSQ) and a demographic questionnaire were mailed during spring 2005 to 960 patients’ home addresses.10 These constituted all living patients who had at any time been prescribed insulin glargine by Malmö University Hospital, Clinic of Endocrinology (or any other clinic) until December 2004, as described in the electronic medical records.
An introductory letter explained the purpose of the study, assuring participants’ anonymity and free-will participation. After three weeks a reminder was sent to all 960 patients. The DTSQ Status Version (DTSQ-s) was used in this survey.10 This instrument measures satisfac-tion with the treatment regimen (six items), perceived frequency of hyperglycaemia (one item) and per-ceived frequency of hypoglycaemia (one item) over the previous few weeks. The DTSQ has previously been translated from English to Swedish and validated,11 and is rec-ommended by the World Health Organization (WHO), the Internat-ional Diabetes Federation (IDF)12 and the Swedish Nurses’ Associa-tion13 for use in the quality assur-ance process for diabetes treatment programmes.
The demographic question-naire contained questions about age, sex, type of diabetes, diabetes-related complications, duration of therapy and previous insulin treat-ment. The patient was also asked an open question about whether he/she wished to switch insulin glargine for another treatment, and the reasons for his/her response. In addition, the medical records of all patients who were ever pre-scribed insulin glargine from our clinic (n=913) were reviewed, to assess HbA1c levels at the time of starting insulin glargine treatment and after a period of 12 months, and to establish the reasons for stopping insulin glargine if this occurred.
Ethics
The Regional Ethic’s Review Board in southern Sweden approved the study. Returning the questionnaire was accepted as patient consent to participate.
Statistics
The descriptive statistics used were percentage, range, mean and median when appropriate. As DTSQ-s scores do not show normal distribution, medians are presented. The computer programs Excel (ver-sion 2000) and SPSS (ver(ver-sion 11.0) were used.
Results
Completed questionnaires were returned by 615 patients. Baseline information and details of previous basal insulin treatment are given in Table 1. The patients reported between 0 and 5 diabetes-related complications (Table 2). Indications for prescribing insulin glargine were (more than one answer possible): • At the physician’s/nurse’s
sugges-tion, 49.2%
• Patient wished to experience less fluctuation in blood glucose, 45.6%
• Patient wished to achieve better metabolic control, 32.1%
• Patient wished to experience fewer hypoglycaemic events, 21.6%
• Patient wished to take one injec-tion instead of two, 14.7% • Other reasons, 14.7%.
According to the medical records, at the time of the first insulin glargine prescription in patients with type 1 diabetes, mean HbA1c values were 7.67%; for patients with type 2 diabetes the mean value was 8.15%. After 12 months’ insulin glargine treatment, the mean HbA1c levels were 7.26% for type 1 diabetes patients and 7.47% for those with type 2 diabetes. This represents a reduction of 0.41% in HbA1clevels for patients with type 1, and 0.68% for patients with type 2 diabetes.
At 12 months, 81 patients out of 913 (8.9%) had stopped using insulin glargine. The most com-mon reasons for stoppage were: starting NPH insulin therapy (n=20); starting insulin pump (n=17); deceased (n=15); starting
oral treatment (n=10); starting with mix insulin (n=9); starting insulin detemir (n=7). At this time point, three patients were not receiving pharmacological treatment for their diabetes.
A total of 80% of the 615 patients responding to the survey did not wish to revert to their previ-ous treatment. The reasons were described in the open-ended ques-tion, and were assessed using con-tent analysis. The main reasons for continuation were:
• Experience of a more stable blood glucose level
• Fewer injections
• Fewer hypoglycaemic episodes • Greater freedom
• Increased sense of security. The main reason given by patients who wished to revert to previous insulin treatment (6.5%) was that insulin glargine had not met their expectations of achieving more stable blood glucose levels. The non-response rate for this question was 13.5%.
DTSQ-s results
The questionnaire is presented in two parts: ‘satisfaction with treat-ment’(6–36 points), where higher scores indicate greater rates of satisfaction, and ‘perceived hyper-and hypoglycaemia’ (2–12 points), where lower scores indicate blood glucose levels closer to the ideal and higher scores indicate problems.
The scores are listed in Table 3. Forty-eight patients (7.8%) scored the maximum of 36 for the treat-ment satisfaction section. The max-imum rating score (6 points) was reported by:
• 23% of patients for the question, ‘How satisfied are you with your current treatment?’
• 23.9% of patients for the ques-tion, ‘How convenient have you been finding your treatment to be recently?’
Table 1. Baseline information on patients who completed the Diabetes Treatment Satisfaction Questionnaire Status Version (n=615, 64% of those mailed) Parameter Percentage Sex Male 48.0 Female 52.0 Diabetes type Type 1 74.0 Type 2 20.0 Other/no response 7.0 Previous basal insulin treatment NPH insulin 62.0 No response 17.8 No insulin 10.3 Mix insulin 9.0 Insulin pump 0.5
• 26.1% of patients for the ques-tion, ‘How flexible have you been finding your treatment recently?’ • 28.7% of patients for the
ques-tion, ‘How satisfied are you with your understanding of your dia-betes?’
• 45% of patients for the question, ‘Would you recommend this form of treatment to someone else with your kind of diabetes?’
• 39.5% of patients for the ques-tion, ‘How satisfied would you be to continue with your present form of treatment?’
The median score for all included items was 5. Differences in scoring as determined by gender were not statistically significant.
Patients reported the following rates of complications: no complica-tions, five patients; one complication, two patients; two complications, one patient; three complications, two patients; four complications, one patient. Greater patient satisfaction was reported with increasing age, with the exception of the 12 patients aged >80 years. There was no difference in overall satisfaction between groups of patients with one or more self-reported diabetes complications. The 12 least-satis-fied patients (scoring 6–12 points) did not differ regarding type of diabetes, gender, age or complica-tion rate.
Perceived frequency of hyper-glycaemia or hypohyper-glycaemia each scored a median of 3 points. There was no significant difference between type of diabetes, gender, age or complication rate, in terms of perceived frequencies of these events.
Discussion
The majority of patients experi-enced more stable blood glucose levels, which revealed that the suggestion of treatment change was appropriate and was in line
with MPA recommendations and National Guidelines.4,5
A reduction in HbA1clevels with insulin glargine (0.41% units, type 1 diabetes; 0.68% units, type 2 dia-betes), with a low degree of per-ceived hypoglycaemic events, is expected, taking into account the heterogeneity of a complex patient group that includes patients with diabetic complications, from all
social strata. Perceived frequency of hyperglycaemia scored 3.07 on the DTSQ-s for all patients, which is higher than the 2.8 score included in a study by Witthaus et al.14Part of this scoring difference could be explained by the broad inclusion criteria. There was no difference in the scores between males and females. The hypoglycaemia score of 2.57 that we report for all Table 2. Self-reported diabetes complications by patients responding to a questionnaire about insulin glargine use (not all respondents answered the question)
Type 1 diabetes Type 2 diabetes All diabetes types
n=445 n=118 (including ‘others’) n=599 n (%) n (%) n (%) Hypertension 141 (31.7) 68 (57.6) 220 (36.7) Dyslipidaemia 107 (24.0) 44 (37.2) 160 (26.7) Retinopathy 76 (17.1) 18 (15.3) 96 (16.0) Heart disease 52 (11.7) 29 (24.6) 87 (14.5) Nephropathy 39 (8.8) 14 (11.9) 55 (9.2) Foot ulcer 31 (7.0) 14 (11.9) 46 (7.7) Neuropathy 37 (8.3) 9 (7.6) 46 (7.7)
Table 3. Diabetes Treatment Satisfaction Questionnaire (Status Version) scores obtained from patients receiving insulin glargine
Item (median scores for each item; Type 1 Type 2 All (including 1 = not at all, 6 = most of the time) n=453 n=121 ‘other’) n=615 Satisfaction with treatment:
Satisfaction 5.00 5.00 5.00 Convenience 5.00 5.00 5.00 Flexibility 5.00 5.00 5.00 Understanding 5.00 5.00 5.00 Recommend to others 5.00 5.00 5.00 Wish to continue 5.00 5.00 5.00
Mean treatment satisfaction total 28.54 30.62 28.45 score (out of a maximum total
score of 36 points) Perceived hyper-/hypoglycaemia: Perceived frequency of 3.00 3.00 3.00 hyperglycaemia Perceived frequency of 3.00 3.00 3.00 hypoglycaemia
patients (2.68 for type 1 diabetes; 2.21 for type 2 diabetes) is equiva-lent to the previous study.14
The present study revealed that 75% of the participants were satis-fied with insulin glargine treat-ment; only 6.5% would prefer to change to another treatment. It is important that the physician responsible for treatment recog-nises such patients and prescribes a more suitable treatment according to individual needs. For those who did not wish to change treatment, it is important that their opinion is taken seriously according to National4 and Swedish Diabetes Association6 guidelines, and that access to preferred treatment is also enabled in the future.
A study using the DTSQ con-ducted by Hirsch et al, involving 144 type 2 diabetes patients (com-mencing different diabetes treat-ments) and patient education revealed no differences between those who had more than one diabetes complication after four weeks’ intervention.15This concurs with our findings. Comparison with other studies is difficult as most previous studies using the DTSQ are randomised controlled trials (RCT) that have excluded patients with severe complications. Our score has been collected from patients in everyday clinical situa-tions and our questionnaire pro-duced a relatively high response rate. The present study findings did not reveal any relationship between total score and comorbidity. The high scores obtained for the item about understanding the disease is interpreted as a good reference to the educational programme offered at the clinic. DTSQ-s scores from the present study are compa-rable with the findings of Ashwell
et al,16 despite the fact that their study only included patients with type 1 diabetes.
We believe that patients who
have a high degree of treatment sat-isfaction, a low degree of hypogly-caemia and a low degree of hyper-glycaemia are prone to consume less healthcare resources and expe-rience fewer hospitalisations.
We consider our response rate of 64% to be good, taking into account that questionnaires were mailed to all living patients who had ever started treatment with insulin glargine at Malmö University, with no exceptions. Seven questionnaires were returned from the post office, marked ‘address unknown’. The patients’ general health is not as good as in an RCT setting, but in this way a truer picture is revealed. A relatively small proportion of the patients state that they have type 2 diabetes, which reflects the univer-sity hospital clinic situation. In gen-eral, patients with type 2 diabetes who are treated at university hospi-tals suffer from more diseases and more complications compared with other people with type 2 diabetes.
As the questionnaire was anony-mous, analysis cannot be per-formed on non-respondents. Theoretically, this group might consist of even more severely ill patients. Insulin detemir use was not investigated as the number of patients on this insulin was too small at the time of the survey. In absence of standardised criteria for the assessment of hypoglycaemic events, we consider patients’ sub-jective experiences as being valu-able. One of the targets for using the DTSQ is as a routine part of clinical audit cycles,9 which is how we use the instrument. Hirsch et
al15 described general well-being and specific treatment satisfaction to be different quality-of-life (QoL) dimensions. We do not consider the DTSQ to be a QoL instrument; it is merely a useful tool for evaluat-ing the quality of diabetes care given at a clinic. Measurements of
patient satisfaction with regard to a certain treatment or programme are important complements to bio-medical parameters when RCTs are conducted. Subsequent follow-up in an everyday clinical setting pro-vides the foundation for developing treatment guidelines and improv-ing diabetes care, which have to be perpetual processes. Asking the patients’ opinions might enable patients to become more involved in their care, and might lead to bet-ter collaboration between diabetes team members and patients, and more holistic care. If patients are satisfied with treatment, in this case with a new insulin, and consider it to be meaningful, the possibilities of a positive outcome (eg reduction in blood glucose level, reduced risk of hypoglycaemia and maintained or improved QoL) increase.
In conclusion, this study demon-strated that patients were satisfied with insulin glargine treatment, as measured with the DTSQ-s, and the majority of patients did not wish to change treatment. HbA1c levels were slightly improved.
Conflict of interest statement: Magdalena Annersten Gershater is a member of the Bayer Advisory Board; and Anders Frid has received honoraria for lectures from sanofi-aventis.
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